A Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab in Patients With Metastatic Colorectal Cancer

An Open-label, Multicenter Phase 1 Study Investigating the Combination of RAD001, Cetuximab and Irinotecan as Second-line Therapy After FOLFOX (or XELOX) Plus Bevacizumab (if Given as Part of Local Standard Practice) in Patient With Metastatic Colorectal Adenocarcinoma

This study will assess the safety of RAD001 when given together with cetuximab and irinotecan

Inclusion criteria:

• Age ≥ 18 years old and ≤ 65 years old.
• Patients with metastatic CRC. Confirmation of CRC diagnosis by histological or cytological specimen from original resection of primary tumor.
• Patients who progressed despite prior therapy with FOLFOX (5FU and oxaliplatin) plus bevacizumab or XELOX (capecitabine and oxaliplatin) plus bevacizumab.
• Patients with at least one measurable lesion by RECIST as determined by Computer Tomography (CT) Scan, Magnetic Resonance Imaging (MRI) or physical examination.
• Patients with a WHO performance status of 0 or 1.

Exclusion criteria:

• Patients with Gilbert's syndrome or any other syndrome associated with deficient glucoronidation of bilirubin.
• Patients who are homozygous for the UGT1A1*28 allele as determined by sequencing.
• Patients who have received previous irinotecan-based therapy.
• Prior treatment with an mTOR inhibitor.

Other protocol-defined inclusion/exclusion criteria may apply